Clinical trial · Interventional
Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide for Breast Cancer Patients After Neoadjuvant Treatment.
Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide vs. Standard Technique After Neoadjuvant Chemotherapy in Patients With Node-Positive Breast Cancer. A Randomized Controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the detection rate and the false negative rate of sentinel lymph node (SLN) by superparamagnetic iron oxide (SPIO) alone or in addition to radioisotope and compared to the standard method (blue and radioisotope) after neoadjuvant chemotherapy in patients with node-positive breast cancer converted to node negative after treatment by ultrasound. A randomized controlled trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPIO alone | Device | — | UNRESOLVED |
| Tc+blue dye | Device | — | UNRESOLVED |
| Tc+SPIO | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Tc+blue dye
- description
- Sentinel Lymph Node (SLN) identification and resection using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and sub-areolar injection of vital blue dye before surgery.
- interventionNames
- Device: Tc+blue dye
- type
- EXPERIMENTAL
- label
- Tc+SPIO
- description
- Sentinel Lymph Node (SLN) identification and resection using isotope technique of sub-areolar injection of technetium-99m (Tc-99m) and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®), before surgery.
- interventionNames
- Device: Tc+SPIO
- type
- EXPERIMENTAL
- label
- SPIO alone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven primary invasive breast cancer with clinical stage T1 through T3, N1 through N2, M0 according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, seventh edition * Completed or were planning to undergo neoadjuvant chemotherapy * Prechemotherapy axillary nodal disease confirmed by fine-needle aspiration or core-needle biopsy * The axilla is clinically and radiologically (by ultrasound) negative (ycN0) postchemotherapy and before surgery * Removal of at least two SLNs * Signed informed consent from each patient before study entry Exclusion Criteria: * T4 tumors, cN3 or cM1 * The axilla is clinically and radiologically (by ultrasound) positive (ycN1) postchemotherapy * Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to vital blue dye or radioactive product. * Chronic iron overload * Pacemaker or other metallic implantable device in the chest wall * Failure to submit to medical study for geographical, social or psychological * Patient deprived of liberty or under guardianship * Pregnant or lactating
References
Publications (0)
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